Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02048085
Status:
WITHDRAWN
Last Update Posted:
2018-04-04
First Post:
2014-01-27
Brief Title:
Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis
Sponsor:
Medical Center of South Arkansas
Organization:
Medical Center of South Arkansas
Study Overview
Official Title:
A Randomized Open Label Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to get study up and enrolling
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACAT
Brief Summary:
This study involves doing platelet function testing in patients who have undergone fibrinolysis Fibrinolysis Use of clot busting medicine in heart attack is the standard of care to restore blood flow in blocked arteries as soon as possible after the Heart attack in rural health center where access to cardiac catheterization is one hour away Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo pharmacodynamics and blood levels of both drugs Pharmacokinetics
Detailed Description:
This is an open label randomized pharmacodynamics study to compare platelet function reactivity of ticagrelor and clopidogrel after PCI in sub-set of patients who have undergone fibrinolysis at least 24 hour prior to PCIA total of 70 patients will be enrolled Prior to enrollment patients have already undergone fibrinolysis selected by the treating physician aspirin recommended dose 324 mg on the first day and 81 mg daily thereafter and Lovenox or heparin as per protocol of referring ER Patients will undergo coronary angiography as standard of care and coronary stenting if indicated Prior to angiography patient will be enrolled in this open label randomized protocol to receive clopidogrel or ticagrelor Patients will be randomly assigned in a 11 ratio by open label study to receive either clopidogrel Plavix Sanofi-Aventis and Bristol-Myers Squibb a 300-mg loading dose followed by 75 mg once daily or ticagrelor Brilinta AstraZeneca 180 mg loading and 90 mg twice daily by a computerized system of randomization Patients will receive clopidogrel or ticagrelor daily from enrollment to discharge For patients who did not undergo PCI after enrollment study drugs will be administered up to and including day 8th or hospital discharge whichever comes first Patients will be treated as per standard of care and pharmacodynamics and pharmacokinetic study will be carried as per protocol VerifyNow and VASP assay will be used to measure platelet reactivity for pharmacodynamic evaluation of ticagrelor vs Clopidogrel at specific time points baseline time 0 30 mins 1 hour 2 hours 8 hours and at 24 hours from first oral anti-platelet dose Blood will be collected from the sheath or ante-cubital vein into Vacutainer tubes for platelet function assay as below by VerifyNow and VASP VerifyNow P2Y12 Assay VerifyNow is a turbidimetric based system that measures platelet aggregation in the whole blood8 This instrument measures an optical signal reported as P2Y12 Reaction Units PRU Vasodilator-Stimulated Phosphoprotein Phosphrylation VASP Assay The measure of Vasodilator-Stimulated Phosphoprotein Phosphrylation Biocytex Inc Marseille France a method to quantify P2Y12 receptor reactivity which reflects the extent of blockade of P2Y12 receptor blockade9 Platelet reactivity index PRI is calculated by measuring VASP-P levels by mean fluorescence intensity MFI by stimulation with prostaglandin PGE1and PGE1 plus ADP PRIMFIPGE1-MFIPGE1ADPMFIPGE1100 Pharmacokinetic will be done at 30 min 60 min 120 min 4 hours 8 hours and at 24 hours AUC from time 0-2 hours Cmax at 2 hours and Tmax at 2 hours for key secondary endpoint Will collect Cmax and Tmax at all time points to be consistent ie at 0 30 min 1 hour 2 hour 8 hours and 24 hours when you draw PD measures at those time points and sample will be shipped
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None